Introduction, preparation required by laboratory, Process of Accreditation, difference between NABL certification and ISO 9000 certification

1. PRESENTATION ON:
National Accreditation Board for Testing and
Calibration Laboratories (NABL) -Certification
PRESENTED BY:
ANKIT AGRAWAL
M.PHARM, PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS
BATCH-2010-2011
E-MAIL: ankitpmra@gmail.com
LACHOO MEMORIAL COLLEGE OF SCIENCE AND TECHNOLOGY
DIRECTOR: PROF. (DR.) B.P. NAGORI

2. NABL CERTIFICATION
CHAPTER PLAN:
1. Introduction and Objective of NABL
2. Laboratory Accreditation
2.1 Concept of Laboratory Accreditation
2.2 Requirement of Laboratory Accreditation
2.3 Benefits of Accreditation
2.4 Types of Laboratory can seek Accreditation
2.5 Fields of Testing and Calibration Covered by NABL
3. Preparations Required by Laboratory for Accreditation
4. Process of Accreditation
4.1 Stage I (Filling of Application)
4.2 Stage II (Pre-Assessment audit)
4.3 Stage III (Final Assessment)
4.4 Stage IV (Corrective Reassessment)
4.5 Stage V (Granting of Accreditation)
5. NABL Certification Differ from ISO 9000 Certification
6. Proficiency Testing Programmes Organized by NABL
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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3. NABL CERTIFICATION
7. Criteria for using NABL Symbol
8. International Recognition of NABL
8.1 Asia Pacific Laboratory Accreditation Cooperation (APLAC)
8.2 ISO/IEC 17025
8.3 International Laboratory Accreditation Cooperation (ILAC)
9. References
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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4. NABL CERTIFICATION
1. Introduction and Objective of NABL:
National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of
Department of Science & Technology, Government of India, and is registered under the Societies Act.
NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third-
party assessment of the quality and technical competence of testing and calibration laboratories.
Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories.
In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests /
calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC
17025.
These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India
and abroad, regardless of their ownership, legal status, size and degree of independence.
NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. NABL
also compiles to the requirement of APLAC MR001 for the fulfillment of APLAC MRA and ILAC Arrangements.
Location of NABL Office:
NABL Secretariat is functioning from its office situated at 3rd Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road –
New Delhi 110067.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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5. NABL CERTIFICATION
NABL Secretariat administers and co-ordinates all activities of NABL including accreditation related activities for Testing and
Calibration laboratories.
Registered Office of NABL is located in Department of Science & Technology, Technology Bhavan, and New Mehrauli Road,
New Delhi – 110016.
Office Timing: The working days of NABL are from Monday to Friday. The office timings are from 9-00 a.m. to 5-30 p.m.
2. Laboratory Accreditation:
2.1 Concept of Laboratory Accreditation:
The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of
laboratories to perform specific type(s) of testing and calibration.
Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to
find reliable testing and calibration services in order to meet their demands.
Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited
laboratories.
The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and
providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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6. NABL CERTIFICATION
2.2 Requirement of Laboratory Accreditation:
Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to
find reliable testing and calibration services in order to meet their demands.
Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited
laboratories.
Society also needs to know the technically competent laboratory in fields such as Medical, Forensic, and Food Testing etc.
The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and
providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence.
2.3 Benefits of Accreditation:
1. Potential increase in business due to enhanced customer confidence and satisfaction.
2. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
3. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance
System and are technically competent.
4. Increase of confidence in Testing / Calibration data and personnel performing work.
5. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory
of Accredited Laboratories.
6. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets,
when tested by accredited laboratories.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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7. NABL CERTIFICATION
2.4 Types of Laboratory can seek Accreditation:
The laboratories should be legally identifiable & appropriately registered. They can be a part of a big organization or an
independent entity.
NABL can provide accreditation to:
 Laboratories undertaking any sort of testing or calibration in the specified fields.
 Private or government laboratories.
 Small operations to large multi-field laboratories.
 Site facilities, temporary field operations and mobile laboratories.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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8. NABL CERTIFICATION
2.5 Fields of Testing and Calibration Covered by NABL:
NABL Accreditation is currently given in the following fields:
TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES
 Biological  Electro-Technical  Clinical Biochemistry
 Chemical  Mechanical  Clinical Pathology
 Electrical  Fluid Flow  Hematology and
 Electronics  Thermal & Optical Immunohaematology
 Fluid-Flow  Radiological  Microbiology and
 Mechanical Serology
 Non-Destructive
 Histopathology
 Photometry
 Cytopathology
 Radiological  Genetics
 Thermal  Nuclear Medicine (in-
vitro tests only)
Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and
reliable results. A laboratory may apply for accreditation from as little as one to as many tests / calibrations provided it is
performing these in accordance with NABL criteria.
Classification of the Testing Laboratories has been done on the basis of basic fields of testing. The laboratories doing inter-
disciplinary testing of products, for eg. Textiles, Plastics, Building materials, Metallurgical products, etc. shall have to apply in
relevant field(s) separately depending upon to which field(s) the test(s) belongs.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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9. NABL CERTIFICATION
3. Preparations Required by Laboratory for Accreditation:
1. Laboratory management should first decide about getting accreditation for its laboratory from NABL.
2. It is important for a laboratory to make a definite plan of action for obtaining accreditation and nominate a
responsible person to coordinate all activities related to seeking accreditation. The person nominated should be
familiar with laboratory's existing Quality System. S/he should be formally designated as the Quality Manager.
3. Procure all relevant NABL documents from NABL Secretariat and get fully acquainted with each of these.
4. Laboratory needs to ascertain the status of its existing Quality System and Technical Competence with regards to
requirements for NABL Accreditation. Is the system documented and effective or does it need modification. Does it
need to build the Quality System of the laboratory from scratch?
5. It must be remembered that Quality Manual is a policy document, which has to be supplemented by a set of other
documents like Procedural Manuals, Work Instructions etc. to align the Quality System in accordance with NABL
Criteria. The laboratory must ensure that the procedures described in the Quality Manual and other documents are
being implemented. For preparing Quality Manual or verifying its contents, the laboratory may take help of “Guide
for Preparing Quality Manual" (NABL 160). The laboratory may also get its personnel trained in NABL's training
programme on Laboratory Quality System, Management and Internal Audit.
6. Relevant requirements for NABL accreditation should be discussed amongst concerned staff of the laboratory. This
will enable them to understand their weaknesses and strengths.
7. Quality Manager must conduct an Internal Audit and take corrective actions before applying for accreditation.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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10. NABL CERTIFICATION
4. Process of Accreditation:
4.1 Stage I (Filling of Application):
 Prepare your laboratory's application for NABL accreditation, giving all desired information and enlisting the test(s) /
calibration(s) along with range and measurement uncertainty for which the laboratory has the competence to
perform. Laboratory can apply either for all or part of their testing / calibration facilities. Formats NABL 151, NABL
152 & NABL 153 are to be used by Testing, Calibration and Medical Laboratories respectively for applying to NABL for
accreditation.
 Laboratory has to take special care in filling the scope of accreditation for which the laboratory wishes to apply. In
case, the laboratory finds any clause (in part or full) not applicable to the laboratory, it shall furnish the reasons.
 Laboratories are required to submit five sets of duly filled in application forms for each field of testing / calibration
along with five sets of Quality Manual and Application Fees.
 NABL Secretariat on receipt of application will issue acknowledgement to the laboratory. After scrutiny of application
for it being complete in all respects, a unique Customer Registration Number will be allocated to laboratory for
further processing of application.
 NABL Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application
submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking
necessary corrective action, if any. The laboratory shall submit Corrective Action Report.
After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organised by NABL.
Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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11. NABL CERTIFICATION
4.2 Stage II (Pre-Assessment audit):
 NABL Secretariat shall organise the Pre-Assessment audit, which shall normally be carried by Lead Assessor at the
laboratory sites.
 The pre-assessment helps the laboratory to be better prepared for the Final Assessment. It also helps the Lead
Assessor to assess the preparedness of the laboratory to undergo Final Assessment apart from Technical Assessor(s)
and Total Assessment Man-days required vis-à-vis the scope of accreditation as per application submitted by the
laboratory.
 A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the
concerns raised during audit, if any.
 The laboratory shall submit Corrective Action Report to NABL Secretariat.
 After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organized
by NABL.
4.3 Stage III (Final Assessment):
 NABL Secretariat shall organize the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and
for that purpose appoint an assessment team.
 The Assessment Team shall comprise of a Lead Assessor and other Technical Assessor(s) in the relevant fields
depending upon the scope to be assessed.
 Assessors shall raise the Non-Conformance(s), if any, and provide it to the laboratory in prescribed format so that it
gets the opportunity to close as many Non-Conformance(s) as they can before closing meeting of the Assessment.
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12. NABL CERTIFICATION
 The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the
original copy to NABL Secretariat.
Laboratory shall take necessary corrective action on the remaining Non-Conformance(s) / other concerns and shall submit a
report to NABL within a maximum period of 2 months.
4.4 Stage IV (Corrective Reassessment):
 After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the
Assessment Team and recommends additional corrective action, if any, by the laboratory.
 Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL
requirements as well as commensurate with the claims made by the laboratory in its application.
 Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee.
 Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to
NABL Secretariat.
 Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the
Director, NABL.
 Whenever possible NABL will depute its own technical personnel to be present at the time of assessment as
Coordinator and NABL Observer. Sometimes, NABL may at its own cost depute a newly trained Technical Assessor as
"Observer" subject to convenience of the laboratory to be accessed.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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13. NABL CERTIFICATION
4.5 Stage V (Granting of Accreditation):
 Accreditation to a laboratory shall be valid for a period of 3 years and NABL shall conduct periodical Surveillance of
the laboratory at intervals of one year.
 Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of
accreditation.
5. NABL Certification Differ from ISO 9000 Certification:
ISO 9000 Certification is on Quality System Management only whereas the NABL Accreditation provides formal recognition of
technical competence of the laboratories, thus providing a ready means for customers to find reliable testing and calibration
services in order to meet their demands as well as the Quality system. Accreditation is a higher level activity than system
certification.
Laboratories can be checked and certified for their compliance to international management system standards such as ISO
9000. This involves the auditing of an organization’s quality management system. Although this will give you confidence of the
laboratory’s quality system, it tells you nothing about its technical competence or its ability to provide reliable and accurate test
data that will be accepted by your customers and trading partners.
Proper technical evaluation requires the use of technical experts who can assess the laboratory against internationally accepted
criteria. These criteria are embraced globally in a document called ISO/IEC 17025. Accreditation bodies may also apply
additional technical requirements for evaluating a laboratory, as per requirements of different technical fields.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
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Laboratory accreditation against the standard ISO/IEC 17025 does, however also covers the quality management elements of
ISO 9000. So laboratory accreditation, which is based on ISO/IEC 17025 is a measure of both technical competence and quality
management and is the most appropriate process rather than quality ISO-9000 certification.
6. Proficiency Testing Programmes Organized by NABL:
All NABL accredited testing and calibration laboratories are required to participate in Proficiency Testing Programmes conducted
by NABL or the nodal organizations appointed by NABL. Accredited and applicant laboratories are required to approach NABL
Co-coordinator for Proficiency Testing programs or the nodal laboratories appointed by NABL whenever a PT programme for a
specific testing / calibration is organized by NABL. For calibration laboratories, NPL, Delhi is the main nodal laboratory.
Laboratories are also expected to participate (as far as available and practicable) in international Inter- Laboratory Comparison
/ Proficiency Programmes conducted by APLAC, EA or equivalent organizations. NABL keeps the accredited laboratories
informed about all such international programmes through NABL newsletter / APLAC newsletter.
It is essential for all its accredited laboratories to participate in International / Regional Proficiency Testing Programmes
including APLAC in a manner so that all major areas of scope of accreditation are covered in a cycle of 4 years. This of course
applies to those special areas where Inter-Laboratory Proficiency Testing Programmes are not available.
All applicant laboratories are required to successfully participate in at least one Inter - Laboratory Proficiency Testing in
accordance with ISO/IEC Guide-43. For this purpose all alternative techniques covered in ISO/IEC Guide-43 will be acceptable.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
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15. NABL CERTIFICATION
For calibration laboratories, measurement audits will be considered to be a complimentary effort to Inter-Laboratory Proficiency
Testing. Technical assessors for calibration laboratories will be provided with artifacts with their characterization by National
Physical Laboratory, New Delhi or any other NMI's who are signatory to BIPM like PTB, NIST etc.
7. Criteria for using NABL Symbol:
 All NABL accredited laboratories are expected to use NABL symbol on their letterhead, test / calibration reports and
any other relevant documents. NABL symbol shall be used for the purpose of identifying correctly and unambiguously
the test / calibration services accredited by NABL.
 While using the symbol it shall be ensured by the laboratory that design and its manifestations are not distorted, it
can be reproduced in any single color (preferably black) and any size.
 It shall be responsibility of the accredited laboratory that the use of symbol does not misrepresent the scope of
accredited testing / calibration services. In case where the accreditation sought and granted do not cover all the
activities of the laboratory's services care should be exercised to restrict the use of symbol only to those accredited
activities. The letterheads and publicity materials, brochures, test / calibration reports of the accredited laboratory
bearing the NABL symbol shall cover only the test results under accredited category. For non-accredited category the
laboratory shall use a letterhead without NABL symbol or specially identify those tests/ measurements which are not
covered by accreditation.
 Accredited laboratories shall not authorize the use of symbol for tests / calibration services sub-contracted to other
laboratories, which are not accredited by NABL.
 In case of complaints in this regard from users and other laboratories, NABL shall get the same examined by a
committee and take appropriate action.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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16. NABL CERTIFICATION
8. International Recognition of NABL:
NABL maintains its linkages with the international bodies like International Laboratory Accreditation Co-operation (ILAC)
and Asia Pacific Laboratory Accreditation Co-operation (APLAC). NABL is a full member of both ILAC and APLAC.
NABL is a signatory to ILAC as well as APLAC Mutual Recognition Arrangements (MRA), which is based on mutual evaluation
and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of
test / calibration results between countries to which MRA partners represent.
In order to achieve the objective of the acceptance of test / calibration data across the national borders, NABL operates and is
committed to update its laboratory accreditation system as per international norms. A current NABL criterion for Laboratory
Accreditation is ISO/IEC 17025 standard for testing and calibration laboratories and ISO 15189:2003 for medical laboratories.
8.1 Asia Pacific Laboratory Accreditation Cooperation (APLAC):
It is the group of accreditation bodies in the Asia Pacific region responsible for accrediting calibration, testing and inspection
facilities.
This reduces the need for re-testing of products and therefore saves time and money. APLAC has active programmed for the
development of technical guidance documents, inter-laboratory comparisons (proficiency testing), and for training of laboratory
assessors.
APLAC is recognized by Asia Pacific Economic Cooperation (APEC) member economies as a Specialist Regional Body (SRB).
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17. NABL CERTIFICATION
8.2 ISO/IEC 17025:
ISO/IEC 17025 is the basis for competency of testing and calibration laboratories.
Accreditation to ISO/IEC 17025 requires that:
 The laboratory has a quality system meeting requirements of ISO 9001.
 The lab facility has adequate equipment to perform its testing or calibration tasks.
 The lab facility has adequate laboratory personnel with the competence to perform the calibration and testing.
 In addition most accreditation schemes in the U.S. require proficiency testing amongst the laboratories.
Therefore, ISO/IEC 17025 is recognition of laboratory competence, while ISO 9001 alone is simply recognition of conformance
to a quality system.
8.3 International Laboratory Accreditation Cooperation (ILAC):
ILAC first started as a conference in 1977 with the aim of developing international cooperation for facilitating trade by
promotion of the acceptance of accredited test and calibration results.
In 1996, ILAC became a formal cooperation with a character to establish a network of mutual recognition agreements among
accreditation bodies that would fulfill this aim.
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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18. NABL CERTIFICATION
9. References:
http://www.nabl-india.org.
http://www.fda.org.
http://www.ilac.org/arrangement.htm.
http://www.aplac.org/members/signatories_mra.htm.
THANK YOU
ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)
E-MAIL: ankitpmra@gmail.com
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